Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Chelyabinsk Regional Clinical Hospital56 enrolled

Overview

The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Allograft Bioprosthesis Tricuspid Valve Disease

Interventions

tricuspid valve replacementPROCEDURE

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention. * Intraoperative findings suggested for tricuspid valve replacement rather than repair. Exclusion Criteria: * Pregnancy * Confirmed active drug addiction * Progressive HIV-infection * HIV-infected patients with CD4-cells count less than 250 * Patients with secondary tricuspid valve pathology (left-sided valve disease) * LV Ejection fraction less than 40%

Locations (1)

Department of Cardiac Surgery

Chelyabinsk, Russia

RECRUITING

Outcomes

Primary Outcomes

Mortality

Freedom from all-cause mortality (%)

Time frame: 30-day period after surgery

Stroke

Stroke rate (n,%)

Time frame: 30-day period after surgery

Severe valve dysfunction

Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)

Time frame: 1-year after surgery, annually, assessed up to 3 years

Freedom from prosthetic endocarditis

Number of patients free from prosthetic endocarditis (n,%)

Time frame: 1-year after surgery, annually, assessed up to 3 years

Freedom from reoperation

Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)

Time frame: 1-year after surgery, annually, assessed up to 3 years

New pacemaker implantation

Number of patients, free from pacemaker implantation after surgery (n,%)

Time frame: 1-year after surgery, annually, assessed up to 3 years

Secondary Outcomes

Transvalvular gradient

Peak and mean gradient (mmHg)

Time frame: 1 year after surgery, annually, assessed up to 3 years

Transprosthetic regurgitation

Vena contracta (mm)

Time frame: 1 year after surgery, annually, assessed up to 3 years

Central Contacts

Mikhail Nuzhdin, PhD

CONTACT

0079068608612 austesla2022@gmail.com

Yuri Malinovsky, PhD

CONTACT

0073517493732 mikhailnuzhdin@hotmail.com

Data from ClinicalTrials.gov

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